NCT04495179

A Study of AZD4635 With Durvalumab and With Cabazitaxel and Durvalumab in Patients With mCRPC.

A Phase II, Open-label, Study to Assess the Efficacy, Safety, and Tolerability of AZD4635 in Combination With Durvalumab and in Combination With Cabazitaxel and Durvalumab in Patients Who Have Progressive Metastatic Castrate-Resistant Prostate Cancer (AARDVARC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Male
• Age: 18 Years – 150 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II, international, open-label, two-arm, non-randomised study of AZD4635 in participants with metastatic castration-resistant prostate cancer (mCRPC).

Detailed description

This is a Phase II, international, open-label, two-arm, non-randomised study of AZD4635 in participants with mCRPC. Participants in each arm will be stratified by the presence of measurable soft tissue metastasis (per Response Evaluation Criteria in Solid Tumours \[RECIST v1.1\]) or bone-only metastasis (per Prostate Cancer Working Group 3 \[PCWG3 criteria\]). There will be no formal comparisons between treatment arms. AZD4635 plus durvalumab (Arm A) will consist of 80 participants with mCRPC previously treated with one or more approved new hormonal agent(s) (NHAs) and one or more taxanes or participants who are taxane ineligible. AZD4635 plus durvalumab plus cabazitaxel (Arm B) will consist of 80 participants mCRPC previously treated with docetaxel and one prior NHA. As of November 2020, the Sponsor stopped enrolment in Arm A following decisions at the program level, not related to any safety issues. Ongoing participants in Arm A may continue treatment as planned.

Conditions

• Progressive Metastatic Castrate-Resistant Prostate Cancer

Interventions

Type	Name	Description
DRUG	AZD4635	Subjects will receive AZD4635 orally daily
DRUG	Durvalumab	Subjects will receive intravenous durvalumab every 4 weeks for Arm A and every 3 weeks for Arm B.
DRUG	Cabazitaxel	Subjects will receive intravenous cabazitaxel every 3 weeks

Timeline

• Start date: 2020-08-04
• Primary completion: 2021-11-01
• Completion: 2022-08-08
• First posted: 2020-07-31
• Last updated: 2023-08-09
• Results posted: 2023-08-09

Locations

16 sites across 5 countries: United States, Belgium, France, South Korea, Spain

Regulatory

• FDA-regulated drug study